MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L MEMO 3D RECHORD

Model Number	MRCS28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method code (b)(4) was used as no information regarding the reason for explant is available.The testing method will be determined upon receipt of additional information.Information regarding the reason for explant and the availability of the device is not available at this time.The manufacturer is reporting this event in a conservative manner.
Event or Problem Description
It was reported through patient tracking on (b)(6) 2017 that this device was implanted and then explanted on (b)(6) 2017.No additional information has been provided regarding the reason for explant.
Additional Manufacturer Narrative
Therefore, the root cause of the explant was not an issue with the device itself but due to patient¿s physiology and disease state a full replacement was necessary.
Event or Problem Description
It was discovered that the mitral ring was used in an attempt to repair the patient¿s mitral valve but after inspection and testing the repair, the surgeon decided to replace it.There was nothing thought to be defective with the ring.It was just that the repair attempt did not work and the patient needed a full mitral valve replacement.The ring has been discarded.

• Brand Name: MEMO 3D RECHORD
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; via crescentino sn; saluggia
• MDR Report Key: 6472127
• Report Number: 3005687633-2017-00028
• Device Sequence Number: 13604508
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)210630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: MRCS28
• Device Catalogue Number: ICV1332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR